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Horizon Pharma plc to Present Results from its Phase 3 Teprotumumab Trial (OPTIC) at the 2019 American Association of Clinical Endocrinologists (AACE) Scientific and Clinical Congress

BusinessWire

DUBLIN–(BUSINESS WIRE)–Horizon Pharma plc (Nasdaq: HZNP) today announced that it will present
additional results from its Phase 3 confirmatory clinical trial (OPTIC)
evaluating teprotumumab for the treatment of active thyroid eye disease
(TED) at the 2019 American Association of Clinical Endocrinologists
(AACE) 28th Annual Scientific & Clinical Congress. The
late-breaking oral presentation will be presented on Friday, April 26,
2019.

Positive primary endpoint data from the clinical trial, titled OPTIC
(Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to
Reduce Proptosis with Teprotumumab Infusions
in a Randomized, Placebo-Controlled, Clinical Study), was announced
on February 28, 2019. Detailed new data will be presented at the meeting.

Presentation Details:

About Teprotumumab

Teprotumumab is a fully human monoclonal antibody (mAb) and a targeted
inhibitor of the insulin-like growth factor 1 receptor (IGF-1R).
Teprotumumab is an investigational medicine and its safety and efficacy
have not been established. The Phase
3 OPTIC confirmatory clinical study was conducted at leading centers
in the U.S., Germany and Italy, with co-principal investigators Raymond
Douglas, M.D., Ph.D., Cedars-Sinai Medical Center; and George Kahaly,
M.D., Johannes Gutenberg University Medical Center. In addition to the
Phase 3 OPTIC trial, Horizon is conducting the OPTIC‐X
extension trial to gather further insight into the long-term
efficacy and safety of teprotumumab. The robust clinical development
program for teprotumumab in the treatment of TED includes positive Phase
2 results published in The
New England Journal of Medicine.

About Thyroid Eye Disease

TED is a serious, progressive, and debilitating autoimmune disease with
a limited window of active disease during which it may respond to
medical intervention.1,2 While TED often occurs in people
living with hyperthyroidism or Graves’ disease, it is a distinct disease
that is caused by autoantibodies activating an IGF-1R-mediated signaling
complex on cells within the orbit.3,4 This leads to a cascade
of negative effects, which cause long-term, irreversible damage. Active
TED lasts for up to three years and is characterized by inflammation and
tissue expansion behind the eye.5,1 As TED progresses, it
causes serious damage – including proptosis (eye bulging), strabismus
(misalignment of the eyes), and diplopia (double vision) – and in some
cases can lead to blindness.2,6 Currently, patients must
suffer through active TED until the disease becomes inactive – often
left with permanent and sight-impairing consequences – before they can
have complex and costly surgical procedures that may never fully restore
vision or appearance.5,1,7 People living with TED often
experience long-term functional, psychological and economic burdens,
including inability to work and perform activities of daily living.7,8

About Horizon Pharma plc

Horizon Pharma plc is focused on researching, developing and
commercializing innovative medicines that address unmet treatment needs
for rare and rheumatic diseases. By fostering a growing pipeline of
medicines in development and exploring all potential uses for currently
marketed medicines, we strive to make a powerful difference for
patients, their caregivers and physicians. For us, it’s personal: by
living up to our own potential, we are helping others live up to theirs.
For more information, please visit www.horizonpharma.com,
follow us @HZNPplc on
Twitter, like us on Facebook or
explore career opportunities on LinkedIn.

References

  1. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment,
    and Management. Journal of Ophthalmology. 2015. https://www.hindawi.com/journals/joph/2015/249125/cta/.
    Accessed Feb 22, 2019.
  2. The 2016 European Thyroid Association/European Group on Graves’
    Orbitopathy Guidelines for the Management of Graves’ Orbitopathy. European
    Thyroid Journal.     2 March 2016. https://www.ncbi.nlm.nih.gov/pubmed/27099835.
    Accessed Feb 22, 2019.
  3. Graves’ Ophthalmopathy. The New England Journal of Medicine. 25
    February 2010. https://www.nejm.org/doi/full/10.1056/NEJMra0905750.
    Accessed Feb 22, 2019.
  4. Igs from patients with Graves’ disease induce the expression of T cell
    chemoattractants in their fibroblasts. The Journal of Immunology. 15
    January 2002. https://www.ncbi.nlm.nih.gov/pubmed/11777993.
    Accessed Feb 22, 2019.
  5. Update on thyroid eye disease and management. Clinical
    Ophthalmology.     19 October 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770865/.
    Accessed Feb 22, 2019.
  6. Clinical features of dysthyroid optic neuropathy: a European Group on
    Graves’ Orbitopathy (EUGOGO) survey. British Journal of
    Ophthalmology.     11 October 2006. https://www.ncbi.nlm.nih.gov/pubmed/17035276.
    Accessed Feb 22, 2019.
  7. Quality of Life and Occupational Disability in Endocrine Orbitopathy. DA
    International.     24 April 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689575/.
    Accessed Feb 22, 2019.
  8. Public health relevance of Graves’ orbitopathy. The Journal of
    Clinical Endocrinology & Metabolism.     26 November 2012. https://www.ncbi.nlm.nih.gov/pubmed/23185037.
    Accessed Feb 22, 2019.

Contacts

Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizonpharma.com

Ruth
Venning
Executive Director, Investor Relations
Investor-relations@horizonpharma.com

U.S.
Media Contact:
Matt Flesch
Executive Director,
Product Communications
media@horizonpharma.com

Ireland
Media Contact:
Gordon MRM
Ray Gordon
ray@gordonmrm.ie

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